Surgical Innovations recalls YelloPort Elite 5x70 Optical Trocars due to potential sterility issues. Affected units have specific lot numbers and UDI-DI codes. Consumers should check their items and contact the company for details.
Optical Trocars sterility assurance can not be guaranteed
Surgical Innovations is recalling YelloPort Elite 5x70 Optical Trocars because the sterility assurance cannot be guaranteed. This means the devices might not be sterile, which could lead to infections during medical procedures.
The optical trocars may not be sterile as intended, which can happen during manufacturing or handling. This poses a risk of infection to patients during medical procedures if the devices are used without proper sterility.
Healthcare professionals who use these surgical instruments are most at risk. Patients receiving procedures with these trocars could face infection risks if the devices are not properly sterile.
Check for the lot number 738182 or UDI-DI code (01) 05051986013398 on the packaging. These items are sold under the brand name YelloPort Elite and are prescription-only surgical instruments.
Look for the lot number 738182 or UDI-DI code (01) 05051986013398 on the packaging to confirm if your item is affected.
The sterility assurance for these optical trocars cannot be guaranteed, which could lead to infection risks during medical procedures.
Check for the lot number 738182 or UDI-DI code (01) 05051986013398 on the packaging. These items are prescription-only surgical instruments.
The recall notice does not specify a remedy, so contact Surgical Innovations directly for further instructions.
We’ve drafted a message you can send Surgical Innovations to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2023 — Surgical Innovations Surgical Innovations Hello, I own a Surgical Innovations that is covered by recall Z-1601-2023 from Surgical Innovations. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.